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Logo MIOCHOL-E

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

MIOCHOL-E
LYOPHILIZED POWDER

COMPOSITION:
Each 2 mL of reconstituted solution contains:
Acetylcholine chloride 20 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 15.4 Ophthalmic preparations: Other.

PHARMACOLOGICAL ACTION:
Acetylcholine is a naturally occurring neurohormone, which mediates nerve impulse transmission at all cholinergic sites involving somatic and autonomic nerves. After release from the nerve ending, acetylcholine is rapidly inactivated by the enzyme acetylcholinesterase by hydrolysis to acetic acid and choline.
Direct application of acetylcholine to the iris will cause rapid miosis of short duration. Topical ocular instillation of acetylcholine to the intact eye causes no discernible response as cholinesterase destroys the molecule more rapidly than it can penetrate the cornea.

INDICATIONS:
To obtain complete miosis of the iris in seconds after delivery of the lens in cataract surgery, in penetrating keratoplasty, iridectomy and other anterior segment surgery where rapid, complete miosis may be required.

CONTRA-INDICATIONS:
Safety and efficacy in children have not been established.
Hypersensitivity to the ingredients.

WARNINGS:
If blister or peelable backing is damaged or broken, sterility of the enclosed bottle cannot be assured.
Open under aseptic conditions only.
DO NOT GAS STERILISE.

DOSAGE AND DIRECTIONS FOR USE:
With a new needle of sturdy gauge, 18-20, draw all the solution into a dry, sterile syringe. Replace needle with a suitable atraumatic cannula for intraocular irrigation.
The MIOCHOL-E solution is instilled into the anterior chamber before or after securing one or more sutures. Instillation should be gentle and parallel to the iris face and tangential to pupil border.
If there are no mechanical hindrances, the pupil is rapidly constricted and the peripheral iris drawn away from the angle of the anterior chamber. Any anatomical hindrance to miosis may require surgery to permit the desired effect of the agent. In most cases 1,2 to 2 mL produces satisfactory miosis. The MIOCHOL-E solution need not be flushed from the chamber after miosis occurs. Since the action of acetylcholine is of short duration, pilocarpine may be applied topically before dressing to maintain miosis.
In cataract surgery, use MIOCHOL-E only after delivery of the lens.
NOTE: Aqueous solutions of acetylcholine chloride are unstable. Prepare solution immediately before use. Do not use solution, which is not clear and colourless. Discard any solution that has not been used.

DIRECTIONS FOR USING THE UNIVIAL:
STERILE UNLESS PACKAGE OPEN OR BROKEN
1. Inspect univial while inside unopened blister. Diluent must be in upper chamber.
2. Peel open blister.
3. Aseptically transfer univial to sterile field. Maintain sterility of outer container during preparation of solution.
4. Immediately before use, give plunger-stopper a quarter turn and press to force diluent and centre plug into lower chamber.
5. Shake gently to dissolve drug.
6. Discard univial and any unused solution.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Cases of corneal oedema, corneal clouding and corneal decompensation have been reported with the use of MIOCHOL-E.
Adverse reactions have been reported rarely which are indicative of systemic absorption. These include bradycardia, hypotension, flushing, breathing difficulties and sweating. In the reconstitution of the solution, as described under Directions for Use, if the centre rubber plug seal in the univial does not go down or is down, do not use the vial.
If miosis is to be obtained quickly and completely with MIOCHOL-E, obstructions to miosis, such as anterior or posterior synechiae, may require surgery prior to administration of MIOCHOL-E. In cataract surgery, use MIOCHOL-E only after delivery of the lens.
NOTE: Aqueous solutions of acetylcholine chloride are unstable. Prepare solution immediately before use. Do not use solution, which is not clear and colourless. Discard any solution that has not been used.

INTERACTIONS:
Although clinical studies with acetylcholine chloride and animal studies with acetylcholine or carbochol revealed no interference, and there, is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbochol have been ineffective when used in patients treated with topical non-steroidal anti-inflammatory agents.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT.
Atropine sulfate (0,5 to 1 mg) should be given intramuscularly or intravenously and should be readily available to counteract possible overdosage. Adrenalin (0,1 to 1 mg subcutaneously) is also of value in overcoming severe cardiovascular or bronchoconstrictor responses.

IDENTIFICATION:
A clear, colourless solution in the upper compartment and a white, opaque, dry spongy solid in the bottom compartment.

PRESENTATION:
A dual compartment 2 mL clear glass univial with the two compartments separated by a rubber centre plug. The vial is closed with a rubber plunger stopper secured by means of an aluminium seal.

STORAGE INSTRUCTIONS:
Store below 30°C. Keep from freezing.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
28/15.4/0506

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison avenue
Bryanston Ext. 77
Private Bag X69
Bryanston
2021

Under licence from Novartis Ophthalmics Ltd

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
25/11/96

New addition to this site: May 2004
Source: Pharmaceutical Industry

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